Associate II, Quality

This is where your work makes a difference.

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

• Leads ongoing, daily departmental operations.
• May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; interview/hire, evaluate, train and develop direct reports.
• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
• Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
• Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
• Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans.
• Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills. Support process with timely closure of observations/audit items.
• Oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) and participate in QA/QC multi-site projects as contributor, coordinator or lead.
• Other duties, tasks or projects as assigned.
• Sustain a clean and safe work area using 6S principles.
• Learn, understand and apply rigorous quality standards, SOPs and cGMP.

• High School Diploma, GED, or equivalent required. Must be at least 18 years of age.
• BS in engineering/science or equivalent work experience.
• 3-5 years experience in Quality with a medical device/Pharma company or other similarly regulated industry.
• Strong interpersonal skills and great attention to detail.
• Strong team player with good problem solving, and good verbal and written communication skills.
• Ability to manage people, encourage teamwork and drive decisions.
• Ability to handle multiple projects concurrently, have computer experience and knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Basic English written and oral communication skills adequate to communicate with other team members.

Other duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

We understand compensation is an important factor as you consider the next step in your career. The estimated base salary for this position is $88,000-$121,000 annually. Individual pay is based on location, skills, experience, and other relevant factors.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Baxter is an equal opportunity employer and evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic.

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.

Baxter has discovered incidents of employment scams. To protect yourself, review our Recruitment Fraud Notice.

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Health and well-being benefits include medical, dental and vision coverage that start on day one, and insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) and the 401(k)…